Regulatory Lead Job Description
Regulatory lead
provides regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives, timelines and budgets.
Regulatory Lead Duties & Responsibilities
To write an effective regulatory lead job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory lead job description templates that you can modify and use.
Sample responsibilities for this position include:
Deliver project and brand specific activities assuring they are correct, complete and on-time including registrations, submissions, labeling/advertising initiation/reviews
Ensure consistent application of the regulatory engagement model across APAC
Help coordinate the “KEYS” issue completion process for issues impacting APAC LOBs and Functions
Coordinate requests for MIS related to the APAC regulatory landscape and drive the use of ACCORD and Phoenix to support this
Connect LOBs, Functions and locations across the Region, relevant subject matter experts, to ensure a coordinated approach to regulatory interactions
Identify regulatory themes both internally and externally to help drive a proactive response
Partner with central Supervisory Regulatory Strategy and other Regions’ regulatory oversight teams to review global regulatory letters (OCC/FRB) to assess potential impact on the APAC region
Ensure that regulatory requirements of the Nordic region are fully represented in discussions at Global, Regional and Local levels
With support of QA/Compliance may participate in drawing up and monitoring Company standard operating procedures, checking on their application, in cooperation with superiors
Provide leadership, guidance and tactical support for the development of Shire recommendations on complex global regulatory policy issues which may have global or regional regulatory impact on Shire business goals and operational effectiveness
Regulatory Lead Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Lead
List any licenses or certifications required by the position: UL, RAC, CISA, PMP, FERC, ASQ, CIA, CFA, MDR, EASA
Education for Regulatory Lead
Typically a job would require a certain level of education.
Employers hiring for the regulatory lead job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Education, Business, Technical, Finance, MBA, Chemistry, Technology, Pharmacy
Skills for Regulatory Lead
Desired skills for regulatory lead include:
Drug development process and regulatory requirements
Experience in regional regulatory environment in relevant product area and development stage
Preparation of major regulatory submissions and supportive amendments
Supplements
Provides coaching and mentoring for GRPT members
TA
Drug development
NCQA requirements
PowerPoint
Project
Desired experience for regulatory lead includes:
Demonstrated ability to lead, design and implement best practices
Experience in supporting strategic improvements and delivering measurable change
Strong background in, and familiarity with, APAC’s core businesses
Excellent written and oral communication skills with the ability to present information in varying degrees of detail and form depending on audience
Team player who supports colleagues, shares information and encourages participation
Excellent oral and written communication skills to support report preparation, training of staff, and report review / sign-off with a variety of stakeholders at all levels of the organization
Regulatory Lead Examples
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Regulatory Lead Job Description
Job Description Example
Our growing company is hiring for a regulatory lead. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory lead
- Facilitate the definition and refinement of project scope, goals, tasks and resource requirements
- Lead efforts to monitor project progress and provide corrective action through collaboration and creative problem-solving
- Captures and measures the project completion performance of all assigned projects or programs
- Lead development of Shire’s global response to regulatory policy issues
- Work collaboratively with senior internal stakeholders within R&D and across Shire in particular Government Affairs, Technical Operations, Public Relations and other key functions to develop a single Shire position on key regulatory policy issues and ensure a single Shire voice externally
- Lead cross functional teams in the development of company positions response plans directed to the FDA, other US governmental bodies
- Development, timely communication and submission of written company feedback to the regulatory agency (on relevant draft guidelines and legislation - to EMA Docket, direct policy communications to Agencies ), industry associations, and patient advocacy groups
- Facilitates and leads opportunities to engage the scientific and regulatory community, thereby increasing the visibility of Shire policies and providing opportunities to influence strategic direction of global regulatory policy issues
- Together with senior regulatory and other R&D leadership, manage the development and participate in the public presentation of Shire positions on regulatory issues
- Represent Shire at industry association or professional meetings or committees, attends or contributes to regulatory agencies work groups, regulatory projects, position papers, responses to proposed regulations, draft guidelines, to ensure Shire’s views are taken into account
Qualifications for regulatory lead
- Strong background working with regulators and other governance bodies
- Familiarity with risk management, operational risk and/or audit information and technology
- If applicant resides in New York, energy markets knowledge is required
- Significant experience in futures and/or securities regulation
- Strong business writing and ability to provide samples
- Managing performance assessments and career development activitie
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Regulatory Lead Job Description
Job Description Example
Our growing company is hiring for a regulatory lead. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory lead
- Assists the Regulatory Reporting and Issue Management Team by providing project support when needed
- Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations
- Be aware of commercial launch plans, provide regulatory guidance and strategic risk assessment to regional/local commercial teams and align strategies to ensure efficient collaboration and realistic plans to ensure timely regulatory actions
- In close collaboration with the EU Regulatory strategist Group Lead, ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products
- Will work with the EU A & P Head, EU regulatory strategist Head, Labeling team and Global Regulatory BU Leads and/or GRL to put in place appropriate processes and provide a common approach and partnership centrally, regionally, and locally
- Accountable for providing regional regulatory expertise, guidance/advice to internal groups on the European regulatory environment, including assessment of the impact of new and changing regulations/requirements in European member states on the development of strategic and tactical plans
- Active role in due diligence activities
- Gain clear understanding of European regulatory agencies organizational structure, roles and responsibilities, current regulations
- Ensure appropriate regulatory contact point for local regulatory authorities and external regulatory experts when necessary
- Provide key support to Regulatory Policy team
Qualifications for regulatory lead
- Solid financial services industry background with experience in program management, reporting and/or controls
- Strong track record managing large-scale and complex programs of work
- Understanding of SPL and PIM formats, requirements and guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and conversations
- Company-organized meetings of healthcare professionals
- Master’s preferred or BA/BS with strong pharmaceutical industry experience (pre-clinical, clinical, medical, marketing, sales, manufacturing, operations, or government affairs)
- Experience in at least one regulatory affairs function outside of policy
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Regulatory Lead Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of regulatory lead. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory lead
- Directly manage regulatory staff based in LOC dedicated to cover EEA region
- Lead EU staff meetings and participate in International/Global teams as requested
- Provide continuous assessment of resource requirements and plan resources in accordance, ensuring adequate internal and external staffing levels
- Provide input into the preparation and tracking into the International regulatory budget and ensure responsibilities for the regulatory LOC group expenses
- Develop strong and effective working relationships with local/regional commercial leads and their teams as part as Local R&D Team representation
- Provide strategic regulatory input to European Regional / Local R&D teams (across GRA, GMA, PVRM and other functions)
- Ensure regulatory LOC Leads provide relevant support to market access team (e
- Acting as a point of contact for the assigned projects and interfacing with key corporate functional areas review and completion of processes to ensure appropriate support to all regulatory staff based in LOCs
- Ensure compliance of regulatory activities in Regions that is consistent with Country laws and Shire internal protocols and procedures
- Makes recommendations for regulatory department operating procedures
Qualifications for regulatory lead
- In depth understanding of the FDA and other major regulatory agencies’ organizational structures, regulations, procedures and practices in major markets
- Effective influencing, partnering and diplomatic skills
- Excellent and demonstrated written and oral communication skills
- Ability to advocate effectively in writing and in person
- BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D
- Generally has at least 8-15 years of Regulatory Affairs experience, including equivalent experience in the biopharmaceutical industry
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Regulatory Lead Job Description
Job Description Example
Our company is hiring for a regulatory lead. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory lead
- Ensure that all local product information used locally are up to date
- Collaborate with International RA Strategists to provide regulatory support to the Shire LOC and distributors in South Korea
- Collaborate with International RA Strategists to provide input into regulatory strategy/plans
- Prepare and submit investigational, marketing and variation applications, post-approval reports and other required life cycle management documentation for pipeline and inline products
- Monitor local regulatory requirements and communicate changes that have business impact to GRA and other relevant colleagues to enable the necessary measures can be taken by Shire to comply with new requirements
- Interact with regulators (and local distributors) where necessary to resolve questions or issues raised in the review of a regulatory submission
- Provide input into the internal change control tracking system to coordinate implementation of proposed post-marketing changes
- Initiate Artwork requests according to internal policies of Shire
- Notify GRA and relevant internal stakeholders of major regulatory milestone, submissions and notifications
- Review regulatory documentation prior to submission by the LOC, distributors/consultants to regulators authorities
Qualifications for regulatory lead
- BS/MS in a scientific discipline
- Experience with multinational companies in international/ regional/ global regulatory affairs, with demonstrable experience in a regulatory leadership role
- Direct supervisory/ managerial experience
- Extensive regulatory experience within European RA
- Working experience within the MIDDLE EAST & AFRICA countries, relevant knowledge of other European or International regions is an advantage
- Regulatory or related experience in the pharmaceutical/ biotechnology industry
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Regulatory Lead Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of regulatory lead. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory lead
- Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan
- Translate when necessary key regulatory communications from the local language to English for review and action by GRA and other internal colleagues
- Collaborate with Pharmacovigilance and Risk Management (PVRM) function in acting as the ‘Safety Control Manager’ for the LOC by assuming the role of the ‘Nominated Contact Person for Pharmacovigilance’ (NCPPV) whereby the operational responsibilities will be supported by PVRM and outsourced as required
- Liaise with the Regional Pharmacovigilance Lead to ensure effective communication of safety information and oversight of the local quality management system in collaboration with Pharmacovigilance and Risk Management (PVRM)
- Review and verify regulatory information and submission plan captured within GRA databases when requested to do so
- Act as the main contact for designated portfolio and projects
- Act as the local RA lead in the CMLR process
- Participate in GRA and local LOC cross-functional team meetings
- Complete new and ongoing Shire training according to the prescribed due date
- Participate in ad hoc work stream formed to improve systems and processes within GRA
Qualifications for regulatory lead
- Monitor changes in the South Korean regulatory landscape
- A registered pharmacist in South Korea
- Pharmacovigilance experience in a pharmaceutical company
- Working experience within the TURKEY, relevant knowledge of other European or International regions is an advantage
- Representing the CDO on certain regulatory programs
- Ensuring that external commitments are appropriately structured, committed, planned, resourced and executed